Quality - Project Coordinator

TechDigital Group; Summit (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Project Management Specialist to support a cutting-edge cell therapy facility. This role involves executing project activities, collaborating with various departments, and ensuring projects are completed within quality metrics and timelines. The ideal candidate will have a strong background in project management, excellent communication skills, and a detail-oriented approach to managing multiple projects. If you are passionate about making a difference in the biopharmaceutical field and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• Bachelor's degree required with 4 years of experience in a regulated environment.
• Proven project management skills using MS Project and Smartsheet.

Responsibilities

• Support project timelines and ensure quality metrics are met.
• Generate project documentation and manage activities according to site objectives.

Skills

Project management

MS Project

Smartsheet

Prioritization skills

Communication skills

Data evaluation

cGMP knowledge

Time management

Education

Bachelor's degree in Science or Engineering

4 years relevant work experience

Tools

Statistical tools

Job description

100% Onsite

The Project Management Specialist of CPV & CI, within the MSAT organization, will support the project timelines, to support the Summit, NJ Cell Therapy facility.

The Project Specialist provides project management support ensuring projects are executed within established quality metrics, budgets and timelines. This includes planning, developing, implementing and evaluating projects, coordinating project activities, collaborating with project team members, developing measurable project goals and objectives and monitoring progress toward achievement. This also includes supporting the development of project management and continuous improvement competencies. The Project Specialist participates in project development, disseminates project information and is an active participant in project execution.

The organization being supported is a 24x7x365 manufacturing facility, located in Summit, NJ.

Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, SBO (Strategic Business Operations) and the broader MSAT organization.

Responsibilities:

1. Execute project activities.
2. Organize and conduct project team meetings and facilitate discussions.
3. Participate in department and site project teams.
4. Generate project documentation (e.g. schedules, status reports) and manage activities according to site objectives and timelines.
5. Demonstrate basic understanding of site quality GxP systems supporting document management, change controls.
6. Participate in planning project related implementation tasks.
7. Interact and collaborate with internal departments, as well as external stakeholders as needed.

Execute departmental activities:

1. Support development of project management and continuous improvement competencies, perform training.
2. Support department staff by:
1. Tracking performance against plan for project activities and deliverables.
2. Compiling project related information, preparing budget proposals and reports in a timely manner.
3. Documenting project risk identification and mitigation plans.
4. Updating project status weekly through the Tier board and iPLAN project dashboards.

Performs other tasks as assigned.

Working conditions:

1. The incumbent will be required to adhere to the current Client policies and procedures.
2. The incumbent will be required to sit at a desk and type/view a monitor for extended periods of time.
3. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
4. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Reports to Associate Director, Manufacturing Science & Technology (MSAT), Cell Therapy

Specific Knowledge, Skills, Abilities:

1. Project management experience using proven methods/tools. Ability to utilize tools like MS project and Smartsheet is a must.
2. Excellent prioritization skills.
3. Able to partner with other groups and make meaningful connections. Being able to negotiate and proactively remediate and prioritize.
4. Basic knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations.
5. Must be detail oriented and able to oversee/manage multiple projects, with a proven track record of impeccable time management, to meet timelines.
6. Possess strong verbal/written communication skills to enable working with internal/external parties and/or leading cross-functional teams.
7. Intermediate knowledge of evaluating data using statistics and statistical tools, to make data driven decisions.
8. Ability to think strategically and to translate strategy into actions.

Education, Experience/Licenses/Certificates:

1. Bachelor's degree required, preferably in Science or Engineering.
2. 4 years' relevant work experience required, preferably in a regulated pharmaceutical environment.
3. Experience within a PMO (Project Management Organization) and/or PM (Project Management) preferred.
4. An equivalent combination of education, experience and training may substitute.
5. Experience with Operational Excellence and Lean Manufacturing is a plus.